EUCTR2011-003304-20-GB
Active, not recruiting
Not Applicable
Randomised Controlled Trial of Intravitreal therapy with Avastin compared to Observation in Patients with Diabetic Ischaemic Macular Oedema‘The DIME study’ - RCT of Avastin in ischaemic diabetic macular oedema (DIME Study)v 1.8
ConditionsIschaemic Diabetic Macular OedemaMedDRA version: 14.1Level: LLTClassification code 10057934Term: Diabetic macular edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10012689Term: Diabetic retinopathySystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10012688Term: Diabetic retinal oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: PTClassification code 10012661Term: Diabetic eye diseaseSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10054372Term: Diabetic retinal edemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10038925Term: Retinopathy diabeticSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: LLTClassification code 10057915Term: Diabetic macular oedemaSystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: HLTClassification code 10012657Term: Diabetic complications ophthalmicSystem Organ Class: 10014698 - Endocrine disordersMedDRA version: 14.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 10015919 - Eye disordersMedDRA version: 14.1Level: HLGTClassification code 10012653Term: Diabetic complicationsSystem Organ Class: 10014698 - Endocrine disordersTherapeutic area: Diseases [C] - Eye Diseases [C11]
DrugsAvastin
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Ischaemic Diabetic Macular Oedema
- Sponsor
- Moorfields Eye Hospital NHS Foundation Trust
- Status
- Active, not recruiting
- Last Updated
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •General Inclusion Criteria
- •Age \>\= 18 years and less than 75 years
- •Diagnosis of diabetes mellitus (type 1 or type 2\)
- •Able and willing to provide informed consent
- •Study Eye Inclusion Criteria
- •The subject must have one eye meeting ALL of the inclusion criteria and NONE of the exclusion criteria listed below.
- •Best corrected ETDRS visual acuity LogMAR (and approximate Snellen equivalent), between 0\.47\-1\.30, 10 working days of randomization. (Equivalent to 6/18 – 3/60\)
- •On clinical exam, definite retinal thickening due to diabetic macular oedema involving the centre of the macula.
- •OCT central subfield \>\=250 µm within 10 working days of randomization.
- •In the opinion of the examining ophthalmologist laser treatment is ineffective or contraindicated because of the state of the Foveal avascular zone (reflecting at least moderate macular ischaemia) on fluorescein angiography. At the point when the ophthalmologist enters into the hospital medical notes that ths individual is not to have further laser treatment, the patient may be considered for inclusion into this study.
Exclusion Criteria
- •General Exclusion Criteria
- •Unstable cardiovascular disease or significant renal disease, (defined as a history of chronic renal failure requiring dialysis or kidney transplant).
- •Known allergy to any component of any study drug.
- •Blood pressure \> 180/110 (systolic above 180 OR diastolic above 110\).
- •Myocardial infarction, other cardiac event requiring hospitalization, stroke, transient ischaemic attack, or treatment for acute congestive heart failure within 6 months prior to randomization.
- •Systemic anti\-VEGF or pro\-VEGF treatment within 4 months prior to randomization.
- •For women of child\-bearing potential: pregnant or lactating or intending to become pregnant within the next 12 months.
- •Any anti\-VEGF treatment to either eye at any time.
- •Study Eye Exclusion Criteria
- •Insufficient patient cooperation to allow adequate fundus photographs.
Outcomes
Primary Outcomes
Not specified
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